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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02894086
Other study ID # RNI2015-35 Pr-REGIMBEAU-2
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 13, 2017
Est. completion date December 13, 2017

Study information

Verified date July 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in France). It mainly affects young adults but is associated with a low complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of care in which the patient is hospitalized for less than 12 hours and does not stay overnight in hospital.

Ambulatory care is based on the guidelines issued by three French learned societies (the SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national priority.

The literature data show that 20% of patients undergoing appendicectomy for acute appendicitis can be treated on an ambulatory basis. However, the success factors for short-stay care (hospitalization <24 hours) or ambulatory care (hospitalization <12 hours) have yet to be identified.

The investigators thus intend to perform a retrospective study of data from the PMSI French national hospital information system, in order to identify factors that are predictive of a length of hospital stay below 24 hours in patients having undergone appendicectomy for acute appendicitis during 2013 in France. The objective is to define the population of patients that could potentially benefit from ambulatory care.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 13, 2017
Est. primary completion date December 13, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

Medical criteria:

- Patients operated on for acute appendicitis between December 2013 and December 2014

Sociodemographic criteria:

- Adult patients (aged between 18 and 75, inclusive)

- Social security coverage

Exclusion Criteria:

Sociodemographic criteria:

- Patients under the age of 18

- Pregnancy or breastfeeding

- Legal guardianship or incarceration

Study Design


Related Conditions & MeSH terms


Intervention

Other:
database.
database

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary identify the population of patients having been hospitalized for less than 24 hours. The ICD-10 diagnostic codes for acute appendicitis, stored in the PMSI. during 1 year (from december 2013 to december 2014)
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